Core C: GMP Cell and Vector Production

核心 C：GMP 细胞和载体生产

基本信息

批准号：
10704663
负责人：
Natalia Lapteva
金额：
$ 28.01万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-11 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10704663
关键词：
Accreditation Address Adverse reactions American Antigen-Presenting Cells Area Australia Cell Therapy Cells Chemistry Clinical Clinical Laboratory Improvement Amendments Clinical Protocols Clinical Research Clinical Trials Contracts Dedications Development Documentation Effector Cell Environmental Monitoring Equipment Europe Far East Flow Cytometry Foundations Generations Genes Genetic Good Manufacturing Process Immune Individual Infrastructure International Investigational Drugs Investigational New Drug Application Knowledge Laboratories Lymphoma Medicine Modification National Heart, Lung, and Blood Institute Outcome Pathologist Phase Plants Population Preparation Procedures Process Production Qualifying Quality Control Quality Indicator Reagent Records Regulation Research Research Personnel Resource Sharing Services Somatic Cell Source System Testing Therapeutic Training Translations United States Food and Drug Administration Validation Viral Vector cell bank cell preparation college experience gene therapy manufacture pre-clinical programs quality assurance translational study vector

项目摘要

PROJECT SUMMARY The three projects comprising this application use immune effector cells to treat lymphoma. Food and Drug Administration (FDA) regulations require that therapeutic cell populations must be manufactured under current Good Manufacturing Practices (cGMP). Core C (Cell and Vector Production) will provide the infrastructure necessary to meet this requirement. The cGMP facility at the Center for Cell and Gene Therapy consists of 22 ISO 7 clean rooms fully equipped for the preparation of cell and gene therapy products. Over the last 23 years, our staff have manufactured more than 7,000 cellular therapy final products (and countless intermediates), and >70 clinical grade viral vectors and master and working cell banks in support of more than 60 IND studies and international clinical protocols. During this period, the facility was designated as a National Gene Vector Laboratory and as a National Somatic Cell Processing Facility under a contract from NHLBI Production Assistance for Cellular Therapy (PACT) program. Manufacturing services are supported by a dedicated specialized flow cytometry laboratory, which performs >13,000 tests annually; a quality control laboratory performing in-house testing and environmental monitoring (>25,000 tests/year); and an independent quality assurance group, which oversees compliance. The program is accredited by the Foundation for the Accreditation of Cellular Therapy, the College of American Pathologists, and under the Clinical Laboratory Improvements Amendments. The Cell and Vector Production facility is registered with the FDA. In addition to manufacturing responsibilities, the Core staff are experienced in transitioning research processes into GMP-compliant procedures and providing regulatory advice. This experience will be essential in supporting the clinical components of this Lymphoma SPORE application.

项目概要该应用程序的三个项目使用免疫效应细胞来治疗淋巴瘤。食品药品管理 (FDA) 法规要求治疗性细胞群必须在以下条件下生产现行良好生产规范 (cGMP)。核心 C（细胞和载体生产）将提供满足这一要求所必需的基础设施。细胞和基因治疗中心的 cGMP 设施由 22 个 ISO 7 洁净室组成，设备齐全，用于制备细胞和基因治疗产品。超过在过去 23 年里，我们的员工制造了 7,000 多种细胞治疗最终产品（以及无数中间体），以及 >70 个临床级病毒载体以及主细胞库和工作细胞库，支持超过 60 项 IND 研究和国际临床方案。在此期间，该设施被指定为国家级基因载体实验室并作为 NHLBI 合同下的国家体细胞加工设施细胞治疗生产援助 (PACT) 计划。制造服务由以下机构支持专门的流式细胞术实验室，每年进行超过 13,000 次测试；质量控制进行内部测试和环境监测的实验室（每年>25,000 次测试）；和一个独立的质量保证小组，负责监督合规性。该计划已获得以下机构的认可细胞治疗认证基金会、美国病理学家学院以及临床实验室改进修正案。细胞和载体生产设施已在美国食品和药物管理局。除了制造职责外，核心人员在研究转型方面也拥有丰富的经验处理成符合 GMP 的程序并提供监管建议。这种经验将是必不可少的支持淋巴瘤 SPORE 应用的临床部分。